Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/149—Probes or electrodes therefor bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/32—Surgical cutting instruments
  • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
  • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/32—Surgical cutting instruments
  • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
  • A61B2017/32004—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes having a laterally movable cutting member at its most distal end which remains within the contours of said end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00053—Mechanical features of the instrument of device
  • A61B2018/00184—Moving parts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00505—Urinary tract
  • A61B2018/00517—Urinary bladder or urethra
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00547—Prostate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B2018/1405—Electrodes having a specific shape
  • A61B2018/144—Wire

Definitions

• the present invention relates to devices and methods for resecting and removing tissue from the interior of a patient's body, for example in a transurethral resection of prostate tissue to treat benign prostatic hyperplasia.
• Electro surgical cutting devices often comprise a shaft or sleeve having a tissue extraction lumen with one or more radio frequency (RF) cutting blades arranged to resect tissue which may then be drawn into the extraction lumen, often via vacuum assistance through a cutting window.
• RF radio frequency
• Most such electro surgical tissue cutting devices rely on manually engaging the cutting window against the target tissue to be resected. While such manual engagement is often sufficient, in other cases, such as in laparoscopic procedures having limited access and field of view, the target tissue can be difficult to visualize prior to resection and, in particular, it can be difficult to assure that the optimum target site has been engaged by the cutting window. For these reasons, it would be desirable to provide improved electro surgical cutting tools having improved visibility and ability engage and immobilize tissue prior to cutting and to extract the tissue from tools after cutting.
• a tissue resecting device comprises an elongated shaft having a central axis, a distal end, and an outer surface.
• An offset housing is mounted on the distal of the shaft and has a tissue-receiving window.
• the tissue-receiving window is offset radially outwardly from the outer surface of the shaft, and a moveable electrode is configured to move back and forth across the window to resect tissue which extends into the window.
• the offset housing improves visibility of the cutting window when viewed from endoscopes and other visualization apparatus.
• the tissue resecting device may be adapted to oscillate laterally across the window.
• a motor may be coupled to the moveable electrode to oscillate the moveable electrode laterally across the window at a rate ranging from 1 Hz to 50 Hz.
• the tissue resecting device may further comprise a negative pressure source communicating with the window through the shaft, and a controller may be adapted to control at least one of an electrical source coupled to the electrode, the motor coupled to the moveable electrode, and the negative pressure source.
• the controller may be further adapted to control fluid inflows from a fluid source to a resection site.
• the window is usually offset outwardly from said outer shaft surface by at least 2 mm, often at least 4 mm, and typically in a range from 2 mm and 12 mm.
• a tissue resecting device comprises an elongated shaft extending about a central axis.
• a housing is attached to a distal end of the shaft and is positioned asymmetrically relative to the central axis.
• a moveable electrode configured to move in a back- and- forth stroke across a tissue-receiving window in the housing to resect tissue.
• the asymmetric housing improves visibility of the window and the ability of the moving electrode to resect tissue.
• the asymmetric housing has an L-shape relative to the central axis.
• the window in the asymmetric housing is aligned in parallel to the central axis and extends radially outwardly from an outer surface of the shaft.
• the electrode is typically adapted to move laterally across the window but alternatively could be adapted to move axially across the window.
• the tissue resecting device may further comprise a motor coupled to the moveable electrode to oscillate the moveable electrode across the window, and the motor may be configured to oscillate the moveable electrode at a rate ranging from 1 Hz to 50 Hz.
• the electrode typically moves in an arc, and a surface of the window has will usually have an arc shape more usually an arc shape congruous with the arc of electrode travel.
• the window may have a rectangular shape, for example with an axial dimension ranging from 2 mm to 20 mm., and/or a lateral dimension ranging from 2 mm to 10 mm.
• the window may have circumferentially or axially spaced-apart edges, and the electrode may be configured to move past those edges.
• the window may have at least two sides with ledges for receiving the electrode at the termination of its stroke.
• a tissue resecting device comprises an elongated shaft extending within a cylindrical envelope. A distal end of the shaft is coupled to an offset housing having a tissue-receiving window. The window has a surface spaced radially outwardly from and oriented generally parallel to the cylindrical envelope. A moveable electrode is configured to move over the window surface and to resect tissue received through the window. As with previous aspects of the present invention, such structures improve visibility of the window and the ability of the moving electrode to resect tissue.
• the tissue resecting device further comprises a motor coupled to the moveable electrode to oscillate the moveable electrode across the window.
• the motor may be configured to oscillate the moveable electrode at a rate ranging from 1 Hz to 50 Hz.
• the window is typically offset radially outwardly from said outer shaft surface by at least 2 mm, often by at least 4 mm, and usually in a range from 2 mm to 12 mm.
• a tissue resecting device comprises an elongated shaft extending to a working end having a tissue-receiving window, said elongated shaft having an outer surface and said window having an exterior surface which is offset radially outwardly from the outer surface of the elongated shaft.
• a moveable electrode is configured to sweep across the exterior surface of the window.
• the tissue resecting device further comprises a motor coupled to the moveable electrode to oscillate the moveable electrode across the window.
• the motor may be configured to oscillate the moveable electrode at a rate ranging from 1 Hz to 50 Hz.
• the exterior surface of the window typically extends laterally in an arc, and the electrode portion moves in an arc over the exterior surface.
• the window may have a rectangular plan shape with an axial dimension ranging from 2 mm to 20 mm and a lateral dimension ranging from 2 mm to 10 mm.
• the electrode is typically configured to move past lateral edges of the window when being swept across the exterior surface of the window.
• the window may have at least two sides with ledges for receiving the electrode at the termination of its stroke.
• the window is preferably within a housing portion that is offset outwardly from an outer surface of the shaft.
• FIG. 1 is a view of a tissue resecting device and a block diagram of systems and operating components corresponding to the invention.
• FIG. 2 is a perspective view of the working end of the resecting device of FIG. 1 showing an asymmetric ceramic housing and moving electrode that is adapted to sweep across a tissue-receiving window.
• FIG. 3 is another perspective view of the working end of FIG. 2 from a different angle.
• FIG. 4A is a schematic view of the working end of FIGS. 2-3 interfacing with tissue targeted for resection under endoscopic vision.
• FIG. 4B is a schematic view of a working end of a prior art tubular cutting device used in a hypothetical resection procedure.
• FIG. 5 is another schematic view of the working end of FIGS. 2-3 being used to resect targeted tissue to a significant depth from the organ surface.
• FIG. 6 is a perspective view of a distal dielectric housing of a working end similar to that of FIGS. 2-3 showing window sides with ledges for receiving the electrode at the ends of its movement in a sweeping arc.
• FIGS. 1 illustrates an electro surgical tissue resecting system 100 for use in urological procedures to resect tissue that includes an introducer sleeve or sheath 102 and a hand-held single-use tissue resecting device or probe 105.
• the resecting device 105 has a handle portion 108 that is coupled to an elongated shaft or extension portion 110 that has an outer diameter ranging from about 2 mm to 7 mm, and in one variation is 5 mm in diameter.
• the shaft 110 extends about longitudinal axis 112 to a working end 115 that is radially asymmetric relative the shaft 110 and its axis 112 as further described below.
• the device is adapted for performing a TURP procedure (transurethral resection of prostate) or a bladder tumor resection procedure and thus the shaft portion 110 extends about axis 112 with a length suitable for introducing in a transurethral approach to reach the targeted prostate tissue or bladder tissue.
• TURP procedure transurethral resection of prostate
• bladder tumor resection procedure a procedure suitable for introducing in a transurethral approach to reach the targeted prostate tissue or bladder tissue.
• the resecting device 105 is adapted for introduction through the introducer sleeve 102.
• Such an introducer sleeve 102 is adapted to receive a commercially available endoscope 130 as can be understood from FIG. 1.
• the resecting device 105 has an elongated shaft 110 that extends to a distal shaft portion 132 that is coupled to an offset resecting housing 140 that has an offset tissue-receiving window 144.
• a moveable electrode 145 is adapted to be driven by a motor drive unit 148 in handle 108 (see FIG. 1) so that the longitudinal portion 149 of the electrode 145 sweeps across the window 144 from side to side to electro surgically resect tissue that is captured in the window 144.
• the targeted tissue can be suctioned into and captured in window 144 by means of a negative pressure source or outflow pump 150 in controller 155 that communicates with a tissue extraction channel 158 extending through the device 105 and terminating in the window 144.
• the configuration of the offset housing 140 is adapted to perform multiple functions. First, the offset housing 140 positions the window surface WS (within curved plane P indicated in FIG. 2) outwardly from the outer surface 160 of shaft 110 which then allows the window surface WS to be fully visible through a endoscope 130 or other viewing means that would be introduced parallel to the device shaft 110 (see FIG. 4A). For example, FIG.
• FIG. 4A is a schematic view of the working end 115 with working surface WS in contact with targeted tissue T.
• the endoscope 130 is positioned with the field of view FV directly aligned with the working surface WS thus allowing optimal viewing of the tissue resection process.
• the outer surface 160 typically defines a cylindrical envelope from which the offset housing 140 projects radially.
• FIG. 4B shows a working end 115' of a conventional dual sleeve tubular cutter having a window surface WS' which when pressed against an organ prevents endoscopic vision of the interface between the tubular cutting edge and the tissue T during a resection procedure.
• the offset housing 140 is adapted for resecting tissue to a greater depth in a localized region of an organ, rather than resecting surface tissues over a broad area. More in particular as shown in FIG. 5, the offset portion 170 of housing 140 can be pushed into tissue perpendicular to axis 112 of the probe shaft 110. Thus, as shown in FIG. 5, the offset housing 140 can be used to resect tissue deep into in a localized region that would not be possible with a resecting device having the configuration shown in FIG. 4B.
• FIGS. 2 and 3 illustrate the asymmetric or offset dielectric housing 140 that can comprise a ceramic material such as zirconium oxide, aluminum oxide or similar materials as is known in the art.
• window surface WS is offset from the shaft outersurface 160 by a predetermined dimension D which can be from 2 mm to 8 mm and in one embodiment comprises a 5 mm offset.
• the width W of the window surface WS around at least portions of the perimeter of the window 144 is a limited dimension, for example less than 3 mm, or less than 2 mm or less than 1 mm. which allows the offset portion 170 of housing 140 to be pushed into tissue perpendicular to the device axis 112 as the electrode 145 sweeps across the window 144.
• one variation of resecting device 105 has an electrode 145 that can be tungsten or stainless steel wire that with electrode portion 149 adapted to sweep across the window 144 at any suitable rate, for example from 1 Hz to 500 Hz.
• the electrode 145 has an elongated proximal shaft portion 176 that extends into handle 108 of the device (FIG. 1).
• the proximal end of electrode 145 is operatively coupled to a motor drive unit 148 and a suitable mechanism or controller is provided to move the elongated electrode proximal shaft portion 176 in an arc to resect tissue.
• the electrode portion 149 moves back and forth akin to a windshield wiper across window 144 in the offset housing 140.
• a number of mechanisms can be used to effectuate the desired movements of the electrode, or the motor drive 148 simply can be controlled by software to move in intermittent clockwise and counter-clockwise directions.
• the elongated electrode proximal shaft portion 176 of the electrode 145 will twist over its length and thus the motor drive 148 can be adapted to rotate the electrode shaft in an arc with radial angle which is greater than the window's comparable radial angle or arc.
• the electrode portion 149 can be expected to move back and forth entirely across the window even when meeting some tissue resistance by compensating for some twisting that is allowed in the elongated electrode proximal shaft portion 176.
• the motor drive unit can be adapted to over-rotate the electrode shaft portion 176 at its proximal end by a selected amount which can be from 10° radial motion to 90° radial motion to compensate for twisting of the electrode shaft portion to insure that electrode portion 149 sweeps entirely across the surface of window 144.
• the window 144 in housing 140 can be configured to have a radial arc relative to the electrode shaft 176 ranging between 30° and 180°.
• the electrode portion 149 has a range of motion that extends across the radial dimension of the window 144 to ensure that any tissue captured in the window is resected as the electrode portion 149 passes the window edges 182a and 182b to function like a shear or in a scissor-like manner.
• the electrode portion 149 moves over ledges 186a and 186b on either side of the housing 140' and can bump into surfaces 190a and 190b.
• any over rotation in the electrode shaft 176 to accommodate twisting as described above can limit the rotation of the electrode portion in the housing 140'.
• the distal tip 192 of electrode portion 149 extends distally beyond window 144 and onto distal ledge 194 in the housing 140' to ensure tissue is resected by the electrode in the distal window region.
• the introducer sleeve 102 has a proximal handle body 202 with a connector 204 that is adapted to couple to connector member 205.
• the connector 205 is adapted to couple to controller 155 and provide within a single cable a first lumen communicating with the fluid outflow pump 150, a second lumen communicating with a fluid inflow pump 225, and a third lumen communicating with a pressure sensor positioned in the controller 155 or in or near the connector 205.
• the introducer sleeve 102 can also accommodate an endoscope 130.
• the introducer sleeve 120 can be assembled with the endoscope 130 (and without the reection device 105) and coupled by connector 205 to the controller 155 to provide an inflow of irrigation fluid from fluid source 226, and outflow of irrigation fluid to collection reservoir 228 together with pressure sensing to allow the assembly to be used in a diagnostic procedure prior to a tissue resection procedure.
• the introducer sleeve 102 can function as a 'continuous flow' optical introducer for use in trans-urethral access to a targeted sire in the prostate or bladder.
• the endoscope 130 can be removed from the assembly 102 and connector 205 can be disconnected from handle body 205. Thereafter, the sleeve portion 240 (see FIG. 1) of introducer assembly 102 can be detached from proximal handle body 204 with the sleeve portion 240 remaining in the patient. Next, the endoscope 130 and connector 205 can be assembled with the resecting device 105 and the physician cam insert the resecting device 105 through the sleeve portion 240 remaining in the patient to access the targeted site. The resecting device 105 and sleeve portion 204 in combination then provide lumens as described above for fluid inflows, fluid outflows and direct pressure sensing through lumens in connector 205.
• the introducer sleeve assembly 102 can include a removable blunt tip obturator that can assist in atraumatic insertion in a patient's urethra.
• one variation of the resecting device as described above has an electrode 145 with a resecting portion 149 that moves radially in an arc relative to axis 112 and a distal window 144.
• Another variation can provide an electrode 145 that reciprocates axially to move across the window 144 and would have similar effectiveness.
• the electrode 145 comprises a first polarity electrode or active electrode and the shaft portion indicates that 245 comprise the return electrode.
• the resecting device 105 can be actuated by moveable finger grip 260 which is adapted to be squeezed toward fixed finger grip 262 to thus move the working end 115 and window surface WS axially back and forth to resect tissue.
• the physician can activate the electro surgical function with a foot switch 265 (FIG. 1) and then reciprocate the working end 115 back and forth from about 5 mm to 25 mm to resect tissue in a path.
• the physician can slightly rotate the shaft of the resecting device 105 so that the window surface WS engages a wider path in the targeted tissue surface.
• the physician would stabilize the sleeve portion 240 and endoscope 130, and then reciprocate and slightly rotate the resecting device 105 during a tissue resection procedure. During such a procedure, the physician can also slightly rotate the sleeve 240 and endoscope 130 to optimize viewing of the targeted tissue.

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• 2016
  • 2016-10-12 EP EP24151142.7A patent/EP4324417A3/en active Pending
  • 2016-10-12 JP JP2018519816A patent/JP2018532497A/ja active Pending
  • 2016-10-12 WO PCT/US2016/056640 patent/WO2017066321A1/en active Application Filing
  • 2016-10-12 CN CN201680070625.2A patent/CN108366808A/zh active Pending
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